Chinese Journal of Pharmacovigilance ›› 2021, Vol. 18 ›› Issue (7): 611-613.
DOI: 10.19803/j.1672-8629.2021.07.03

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Determination of Silicon in Pantoprazole Sodium for Injection by ICP-MS

DUAN Xiying1, WANG Dongyun1, XU Jia1, QIU Yajing1,*, XU Mingzhe2#   

  1. 1Taizhou Institute for Drug Control, Taizhou Jiangsu 225300, China;
    2National Institutes for Food and Drug Control, Beijing 102629, China
  • Received:2021-03-24 Online:2021-07-15 Published:2021-07-23

Abstract: Objective To establish a method for the determination of silicon in pantoprazole sodium for injection. Methods Inductively coupled plasma mass spectrometry (ICP-MS) was used to determine the contents of silicon, while 45Sc was used as the internal standard of 28Si. Results The linear ranges of Si was 100-5 000 ng/mL. The r value was 0.999 9. The RSD of precision was 0.7%, compared to 1.0% for the repeatability test, and 1.1% for intermediate precision. The average recovery rate of low, medium and high concentrations was 102.3% (n=9). Conclusion This method is accurate and sensitive, which can be used for determination of Si in pantoprazole sodium for injection.

Key words: pantoprazole sodium, inductively coupled plasma mass spectrometry, silicon, assay

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